ANZCTR search results

The study aims to analyse the effect of cooling, combined pre-cooling and cooling during exercise, in cycling with a passive cooling vest on core body temperature, heart rate, balance, physical capacity and fatigue of individuals with MS and general people.

Air is currently used as the insufflation agent during colonoscopy to allow for visualisation & detection of colorectal lesions. Recently, there has been a trend towards introducing carbon dioxide as an alternative agent as this reportedly reduces post-procedural discomfort. There have been several trials internationally that have revealed this trend, but none so far in Australia. Our aim is to randomise adult patients with intact colons (those who have not undergone any bowel resection) to either air and carbon dioxide with the aim of assessing and comparing their post-procedural discomfort using a visual analog scale from 0 to 10. Other information such as the time to completion of the procedure and time to reach the end of the colon (that is the caecum) will be obtained. We propose that the use of carbon dioxide as the insufflation agent during colonoscopy is better in terms of improvement of post-procedural discomfort than air.

Intrauterine growth restriction is the term used to describe a condition where an unborn baby does not reach its optimum size. In the short and long term, intrauterine growth restricted babies have a higher risk of serious disease and even death. It is well established that very low levels of oxygen in the baby's blood can harm the baby's health through a state known as oxidative stress. Currently, there is no established treatment available to treat intrauterine growth restriction or its complications. In experimental animal studies however, the naturally occuring hormone, melatonin, has been shown to significantly reduce oxidative stress and improve health of the unborn babies that have suffered from intrauterine growth restriction. This study aims to find out if the use melatonin twice per day throughout pregnancies affected by intrauterine growth restriction will lower the level of oxidative stress experienced by the unborn baby. If this is the case melatonin may help protect the unborn baby from damage caused by oxidative stress, this will be studied in a separate future study.

Although the association of nutritional composition of foods with health parameters is well established, the physical structure can influence the digestion, absorption and consequently may affect caridovascular health indices namely, circulating lipid levels, inflammatory mediators and satiety hormones. Interactions between the nutrients due to food processing can change, influencing the accessibility of the digestive enzymes for hydrolysis. In this context, although type of dietary fat consumed has been shown to modulate blood cholesterol levels, the matrix of the food may influence its cholesterol raising/lowering potential. Accordingly, the rate of absorption of fat from a meal containing whole almonds has been shown to be much slower compared to almond oil. The aim of this project is to examine the effects of matrix in which almond lipids are complexed on postprandial lipid levels, inflammation markers, and satiety hormones. This will be achieved by determining the effects of feeding four different almond preparations, i.e. lipids trapped within the cell walls (raw almonds), oleosin-stabilized lipid emulsion (almond extract or milk), casein-stabilized lipid emulsion (almond oil emulsion) and lipids as free oil (almond oil). We hypothesise that the rate of absorption of fat from almonds, almond oil and emulsified almond oil will be different and in turn may influence cardiovascular disease risk factors.

Background & Aim There is a controversy on whether listening to music prior or during colonoscopy reduces anxiety, pain and improves satisfaction and compliance with the procedure. In particular, music has been found to reduce anxiety around colonoscopy in a number of studies. However, these studies only used first time colonoscopy patients, self-selected music for 15 minutes prior to the procedure and were focusing on pre-procedural anxiety. Further, only one previous study used theory to design a specific music track. However, the music used there was Turkish classical music and thus studies with Western populations and music known to them are needed to avoid possible cultural bias. Future studies should explore theory based interventions since the majority of current studies (i.e. using self-selected music) did not explain why this method was chosen, did not record the frequency of each genre of music selected or did not consider it in their analysis and controversies in findings may be due to particular designs rather than theory versus self-selected music. In addition, one previous study found that providing self-selected music via headphones during the procedure significantly reduced the self-reported pain. However, other studies in which background music or self-selected music via headphones was used during the procedure showed no significant differences in pain between the conditions. Further, several previous studies have shown that music (both self-selected and investigator selected) may reduce the sedation required during colonoscopy. Music has also been shown to increase the patient satisfaction of colonoscopy. Thus, this study aimed to establish whether specifically designed music significantly affects anxiety, pain and experience associated with colonoscopy. Methods This semi-randomized controlled study selected music, using theory, for the purpose of relaxation. Thirty-four day patients undergoing a colonoscopy were provided with either muted headphones (n=17) or headphones playing the investigator-selected music (n=17) for 10 minutes prior to and during colonoscopy. Anxiety, pain, sedation dose and overall experience were measured using quantitative measures and scales. Results Participants’ state anxiety decreased over time (p<0.001). However, music did not significantly reduce anxiety (p=0.441), pain scores (p=0.313) or midazolam (p=0.327) or fentanyl doses (p=0.295). Despite these findings, 100% of the music group indicated that they would want music if they were to repeat the procedure, as compared to only 50% of those in the non-music group wanting to wear muted headphones. The majority would not want to pick their own music. Conclusions Although no significant effects of music on pain, anxiety and sedation were found, a clear preference for music was expressed, therefore warranting further research on this subject. Larger studies are needed and data on the most appropriate music for colonoscopy should also be obtained as all music may not be equally efficacious.

The proposed study is a randomized controlled trial of two evidence-based treatments for late-life depression for patients who also have at least one co-morbid health problem. Participants will be randomised to two active interventions (ie PST or CBT) or treatment as usual (TAU). Randomization will be stratified by diagnosis: major depressive episode or minor depression/dysthymia, using computer-generated random numbers. All assessments will be completed by a researcher that remains blind to the allocation throughout the study. Participants will be assessed, using a range of questionnaire measures and a diagnostic interview, at pre and post-treatment, 6, and 12 months follow-up.

This study aims to determine the safety and efficacy of treatment with a tyrosine kinase inhibitor (TKI) and pegylated interferon in patients with previously untreated chronic myeloid leukaemia (CML). Who is it for? You may be eligible to join this study if you are aged at least 18 years and have been diagnosed with CML. You must have received no previous treatment for CML. Trial details All participants in this trial will commence treatment with the TKI oral nilotinib alone for 3 months. Provided the drug is tolerated, participants will commence injections of pegylated interferon at a dose of 30 micrograms per week. After a month of pegylated interferon and nilotinib treatment, and provided the pegylated interferon is tolerated, patients will escalate pegylated interferon treatment to a dose of 50 micrograms per week in combination with nilotinib. Participants will be assessed at regular timepoints until the end of the trial to determine the safety and clinical benefit of the treatments. Treatment duration will be a minimum of 24 months. This Phase II study will: Investigate the survival benefit, the rate of remission and safety of the patients allocated to each group and compare the groups to eachother.

The Brien Holden Vision Institute (previously known as the Institute for Eye Research) conducted a clinical trial to test commercially-available multifocal contact lenses for their potential to control the progression of myopia in children(IERP2007-009, ACTRN12611001148965; http://www.anzctr.org.au/trial_view.aspx?ID=347659 ). The trial was completed in 2008. Approximately half of the 40 children who participated in trial IERP2007-009 were enrolled in a subsequent myopia control trial at the Brien Holden Vision Institute (IER2008-001, ACTRN12611001141932; http://www.anzctr.org.au/trial_view.aspx?ID=347655 ) in which all participants wore the test product of trial IERP2007-009. Both IERP 2007-009 and IER2008-001 have provided valuable information on the efficacy of the multifocal contact lenses in controlling the rate of progression of myopia. This research is based on the hypothesis that the peripheral retina plays a role in controlling the refractive development of the eye as shown in animal experiments (Smith et al. 2007). In this study, the participants will continue to wear the commercially available multifocal contact lenses used in the previous two trials (IERP2007-009 and IER2008-001) to see whether the efficacy of controlling myopia with this lenses will still remain true for a longer period of time.

This study aims to assess a number of new treatments over time. The aim is to continue to improve treatment by comparing a number of new drugs which have shown some benefit in early stage trials with the existing standard treatment. The current treatment option which will be tested in Australia is standard treatment, low dose Cytarabine alone compared with standard treatment, low dose Cytarabine in combination with Tosedostat in elderly patients with either acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS). Who is it for? You may be eligible to join this study if you are aged 60 years or over and have been diagnosed with AML or MDS. You must have received no previous treatment for AML. Trial details Additional experimental treatments may be added or removed from the study as further information becomes available. The current treatment option which will be tested in Australia is standard treatment, low dose Cytarabine alone compared with standard treatment, low dose Cytarabine in combination with Tosedostat in elderly patients with either acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS). All participants in this trial will undergo chemotherapy for four cycles. Participants will be randomly (by chance) allocated to one of two groups. One group will receive the together subcutaneous injections of low dose cytarabine together with Tosedostat tablets in a dose of 120mg (2 capsules) orally once a day with a glass of water after food, preferably in the morning at about the same time every day to ensure an even dose interval. Treatment should commence on day 1 of the first course of Low dose Ara-C and continue daily for 6 months. Patients may stay on treatment if they are deriving benefit. The other group will receive low dose cytarabine by subcutaneous injection alone. Participants will be assessed at regular timepoints until the end of the trial to determine the safety and clinical benefit of tosedostat treatment in combination with low dose cytarabine, compared to the current effective treatment of low dose cytarabine alone. Treatment Duration will be a minimum of 4 courses between 28 and 42 days each. This Phase II/III study will: Investigate the survival benefit, the rate of remission and safety of the patients allocated to each group and compare the groups to each other

This study aims to determine the safety and efficacy of treatment with the drug midostaurin, in combination with intensive chemotherapy for adults with previously untreated core binding factor (CBF) acute myeloid leukaemia (AML). Who is it for? You may be eligible to join this study if you are aged between 15-65 years and have been diagnosed with AML with CBF subtype. You must have received no previous treatment for AML. Trial details All participants in this trial will undergo intensive chemotherapy over a period of 18 months, that will include the addition of midostaurin twice a day during some of that time. Midostaurin is a new chemotherapy drug thought to be particularly effective in CBF AML. Participants will then be assessed at regular timepoints for between 1 to 5 years to determine the safety and clinical benefit of midostaurin treatment in combination with chemotherapy. This Phase II study will: Investigate the clinical benefit, safety and potential extended survival following therapy with frontline midostaurin in combination with chemotherapy and during maintenance therapy in adult AML